Urine flow problems include urine retention, incontinence, and difficult urination. These problems, especially retention and ischuria, can have serious consequences. Retention can result from any of a number of causes, including without limitation, spinal cord injury or tumors, coma, typhoid, peritonitis, prostatic enlargement, urethral stricture, urethritis, cystitis, bladder tumors, urethral calculus, Parkinson's disease, prostatitis, or multiple sclerosis. Patients suffering from these and other conditions often require some interventional means to periodically drain the bladder. Failure to do so can result in damage of the epithelium and detrusor muscles associated with the bladder, and an increased potential for bacterial invasion and urinary tract infection.
The urine flow problem of incontinence is the inability to retain urine. Incontinence can result from paralysis or relaxation of the sphincters or contraction of the longitudinal muscular layers of the bladder. Incontinence can also occur in coma, epileptic seizure, spinal cord injury or tumors associated with the spinal cord, spinal meningitis, or local irritation of the bladder. Incontinence may be categorized as either stress incontinence, in which urine is expelled during stresses such as exercise, coughing, and laughing; urge incontinence, in which the patient in unable to control the urge to urinate in part due to uninhibited bladder contractions; or mixed incontinence, in which the patient experiences both stress and urge incontinence.
Difficult urination or dysuria can result from urethral strictures, enlarged prostates, atony and impairment of the bladder's muscular power, and inflammatory conditions involving the urethra, bladder, or lower ureter.
Devices have been developed to be positioned in the urethra and/or bladder to correct the problems of urine flow. These devices, including urinary drainage catheters, have been used for many years. A device of this type requires proper placement in the urethra in order to operate correctly and with minimal discomfort. It can be difficult to properly position a urine-control device in the urethra. Some of these urethral devices require that a physician use a cystoscope or rely on ultrasound, fluoroscopy, X-ray, or similar technology for position information to properly place a device in the urethra. These techniques require relatively expensive equipment. Another way that it can be determined that a urethral device has been positioned into the bladder is to observe the flow of urine through the device which is an indication that the bladder has been entered. This method requires that a through-lumen or valve can be maintained in an open position during insertion and that the bladder be sufficiently full so that a flow of fluid is readily observable. Therefore, this method may not be available if the patient's bladder is empty. Accordingly, devices for placement in the urethra are relatively hard to properly position and have often required that a skilled physician position the device using expensive equipment.
Accordingly, it is an object to provide a urethral device that can be positioned relatively easily.